WEDNESDAY, October 10
7:30am Registration and Morning Coffee
8:30 am Chairperson’s Opening Remarks
Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen
» 8:35 KEYNOTE PRESENTATION
Antibody-Targeted Cancer Immunotherapy
Louis M. Weiner, M.D., Director, Oncology, Lombardi Comprehensive Cancer Center, Georgetown University
Antibodies have emerged as versatile and potent cancer therapy agents, exploiting properties such as signaling perturbation, delivery of toxic payloads and activation of anti-tumor immune responses. Work related to manipulation of immune responses will be discussed with a perspective on aligning antibody structural properties and effects on tumor cell signaling with clinically relevant mechanisms of action.
» 9:35 FEATURED PRESENTATION
Impact of Immunogenicity on PK Profiles of Novel Large Molecule Constructs
Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen
An assessment of immunogenicity in single dose and multiple dose studies on clearance of novel drug constructs will be discussed and compared to fully human monoclonal antibodies.
10:05 Regulatory and Quality Considerations When Developing Novel Antibody-Related Constructs
Audrey Jia, M.D., Ph.D., M.S., Monoclonal Antibody Quality Reviewer, Division of Monoclonal Antibodies in the Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
This talk discusses the unique features of novel antibody-related constructs, their regulatory challenges and quality considerations from a quality reviewer’s perspective.
10:35 Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
11:10 Chairperson’s Remarks
Birgit Schoeberl, Ph.D., Vice President, Discovery, Merrimack Pharmaceuticals
» 11:15 KEYNOTE PRESENTATION
Applications of Pharmacokinetic/Pharmacodynamic Modeling to Expedite Development of Novel Constructs
Joseph P. Balthasar, Ph.D., Professor, Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, SUNY Buffalo
12:15 pm Sponsored Presentation (Opportunity Available)
12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
2:20 Bench to Bedside Translation of Antibody Drug Conjugates Using a Multiscale Mechanistic PK/PD Model: A Case Study with SGN-35
Dhavalkumar K. Shah, Ph.D., Senior Scientist, Modeling & Simulation, Pfizer
The presentation will layout a 7 step procedure to build and validate a novel multiscale mechanism based PK/PD model for ADCs, using SGN-35 as an example. The model is designed to integrate pre-clinical biomeasures and PK/PD data for pre-clinical to clinical translation of ADC efficacy. The presentation will highlight that it is essential to understand and characterize the disposition of ADC and payload, at cellular and physiological level, to better predict the clinical outcome of ADCs.
2:50 Talk Title to be Announced
Birgit Schoeberl, Ph.D., Vice President, Discovery, Merrimack Pharmaceuticals
3:20 Refreshment Break in Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
4:00 A Generic Physiologically-Based Pharmacokinetic Model for Biologicals
Christoph Niederalt, Ph.D., Senior Scientist, Systems Pharmacology, Bayer Technology Services GmbH
A generic physiologically-based pharmacokinetic (PBPK) model for biologicals that can describe relevant distribution and clearance processes in different animal species and humans will be presented. The model will be illustrated by examples wherein non-standard processes such as target-mediated deposition and clearance are accounted for and discussed.
4:30 Combining Systems Biology and Pharmacokinetic Models to Translate in vitro Results into in vivo Efficacy
Ben-Fillippo Krippendorff, Ph.D., Department of Oncology and Cancer Research UK, Cambridge Research Institute
In this talk we present a new modeling approach to combine in vitro derived knowledge about target dynamics into pharmacokinetic models. For the example of inhibiting growth factor signaling in cancer we advocate the potential of such systems pharmacology approaches to predict target dynamics in vivo from systems biology models derived in vitro.
5:00 – 6:00 Breakout Sessions
PK/PD Models for ADCs
Moderator: Dhavalkumar K. Shah, Ph.D., Senior Scientist, Modeling & Simulation, Pfizer
• Modeling the intracellular processing of ADC and payload in tumor and normal tissues
• Use of PK/PD models to aid in the in-vitro/in-vivo correlation of ADC efficacy and safety
• Characterize the disposition of ADC and payload into tumor and normal tissues (i.e. effect of target expression and linker chemistry)
• Modeling the preclinical efficacy of ADCs (including bystander effect) to aid in the preclinical to clinical translation of efficacy
• Use of PK/PD modeling to guide clinical dose regimen, FIH starting dose (Based on efficacy vs. Safety), and patient stratification (to aid precision medicine efforts).
Impact of Immunogenicity and PK Profiles
Moderator: Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen
• Impact of binding and neutralizing antibodies on PK
• Statistical Modeling of ADA profiles on single dose and multiple dose PK studies
• Magnitude and timing of ADA response and impact on exposure
6:00-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
7:00 End of Day One